Clinical Research Safety Specialist - Remote US

**It’s More Than a Career, It’s a Mission.** Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community\-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission\-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. **Our Mission** People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting\-edge research, SCRI is redefining cancer care around the world. The **Clinical Research Safety Specialist** plays a critical role in supporting regulatory compliance and patient safety across clinical research studies. Primary responsibilities include preparing and submitting documentation to Institutional Review Boards (IRBs), maintaining regulatory files related to IND Safety Reports and Investigator Brochures, and ensuring accurate and timely documentation throughout the lifecycle of clinical trials. In addition, this position supports regulatory affairs activities for both industry\-sponsored and investigator\-initiated studies, helping to ensure ongoing compliance with applicable regulations, protocols, and sponsor requirements. The **Clinical Research Safety Specialist** collaborates closely with Regulatory Affairs leadership, study teams, and Principal Investigators to facilitate regulatory processes, maintain inspection readiness, and support internal and external audit activities. **This is a remote position based in the US; relocation assistance, and visa sponsorship are not available.** **Key Responsibilities:** * Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies. * Maintain and organize IND Safety Reports, Investigator Brochures, and other essential regulatory documentation. * Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies. * Assist with regulatory submissions and ongoing regulatory affairs activities for industry\-sponsored and investigator\-initiated clinical trials. * Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met. * Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files. * Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance\-related activities. * Other duties as assigned This role requires exceptional attention to detai